The application is the U.S. Patent Application Serial Number 11/136 of the common pending trial in submission on May 24th, 2005, the part continuation application of 141, this part continuation application is the part continuation application of the U.S. Patent Application Serial Number 10/914,629 (now abandoning) in submission on August 9th, 2004.
The description of preferred embodiment
Although be detailed and accurately to enable those skilled in the art realize the present invention, physical embodiment disclosed herein only example the present invention can be embodied in other specific structure in this disclosure.Although describe preferred embodiment, can change details without deviating from the invention, the present invention is defined by the claims.
I. constrictor assembly
Fig. 1 and Fig. 2 shows the representative configuration of constrictor assembly 10 respectively with assembled view Sum decomposition view, (namely it be configured for fixing fracture according to size design, the position of fixing same bone), or for the bone (i.e. fixing contiguous and/or two of connecting or more root list bone) of fixing (arthrodesis) to be fused.In order to simple expression, sometimes assembly 10 will be referred to as bone and fix/merge compression assembly, to show that it can perform fixed function between two or more root list bones, or perform fusion function between two or more positions of same bone, or perform this two kinds of functions.As used herein, " bone section " or " contiguous bone region " refers to any one in following two kinds of situations, that is, the fracture line in single bone, or gap between different bone section or joint.In FIG, in order to illustrated object, show schematically show the bone region of bone section or vicinity and there is no anatomical details.Afterwards, such as, in Figure 13 to Figure 16 and Figure 20 to Figure 22, arrange with concrete anatomy and show bone section or contiguous bone region, be included in the joint between the rumpbone of basin bone and ilium, be anatomically also called sacroiliac joint (SI-joint).
As shown in Figures 1 and 2, constrictor assembly 10 comprises anchoring body 12, and its (as shown in Figure 1) to be placed in bone section or contiguous bone region according to size design with being configured to pressurized.In representational embodiment, anchoring body 12 takes the form of cylindrical anchor pin or bar.But anchoring body 12 can have other geometry.
The distal anchor of anchoring body 12 is affixed to far-end anchor screw 14, and this far-end anchor screw 14 is coupled to the interior bone region in the side in gap or joint.The outside bone region being fixed to the opposite side in gap or joint proximally by anchoring nut 16 and anchoring packing ring 18 of anchoring body 12.Far-end anchor screw 14 and anchoring nut 16 make anchoring body 12 keep pressurized, and in this case, anchoring body 12 compresses and fixes bone section or contiguous bone region.
Anchoring body 12 in bone region or bone section has Tubular implants structure 20 that is microscler, bar sample.Implant structure 20 comprises internal bore 22, and this internal bore 22 receives it to arrange by sliding on anchoring body 12.As shown in Figure 2, implant structure 20 comprises region 24, this region 24 along implant structure 20 length formed at least partially to promote to grow in bone on body structure surface or in body structure surface and/or pass completely through the osteogenesis of a part of entire infrastructure or structure.Grow in the bone on the surface of implant structure 20 or wear osteogenesis region 24 and facilitate on implant structure 20, in implant structure 20 or through growing in the bone of implant structure 20 or wearing osteogenesis.On implant structure 20, in implant structure 20 or through growth in the bone of implant structure 20 or wear that osteogenesis helps to accelerate to keep pressurized and the fusion process in the bone section of being fixed by anchoring body 12 or contiguous bone region or healing time.
A. anchoring body, nuts and washers
Anchoring body 12, nut 16 and packing ring 18 can such as be formed by machining, molding or the material extruded by can be used in prosthese technology, it can be put into and keep compression stress, and does not suffer the obvious bio-absorbable of surrounding bone or tissue along with the time or absorb.Anchoring body 12, nut 16 and packing ring 18 are intended to being enough to make fracture or retaining in place in fusion site stable time.The example of such material includes but not limited to, titanium, titanium alloy, tantalum, chromium cobalt, surgical steel, or other whole joint replacement metal any and/or pottery, sintered glass, artificial bone, any uncemented metal or ceramic surface, or its combination.
In length (see Fig. 1), anchoring body 12 by according to size design to span through bone section or the region of a vicinity, by gap between or joint, and enter the distance in other contiguous bone section or region at least in part.According to topology according to the length of size design anchoring body 12 and diameter.Usually, medical professional can utilize the anatomical textbook of skeleton and they to the knowledge of position and i or I thereof to understand the form of partial structurtes.Doctor can also utilize such as planar film x-ray, cryptoscope x-ray on the basis of the ex ante analysis of the form in targeted bone region, or MRI or CT scan determine the size of anchoring body 12.The representational diameter of anchoring body 12 can scope between 3.2mm to 3.5mm.
Illustrate as best in Fig. 2, at least proximal end region of anchoring body 12 and remote area comprise external spiral spiral shell ridge or screw thread 26 and 28, and its cylinder around anchoring body 12 is formed.Alternatively, if wish, anchoring body 12 can substantially along its whole length be threaded.Desirably, at proximal end region and the remote area of anchoring body 12, screw thread 26 is identical with the direction of 28, and such as, it desirably comprises right-hand thread.
The proximal end region being threaded the anchoring body 12 of 26 by according to size design with the extension certain distance in use in an adjacent bone section or region.By this way, proximal end region is exposed can be attached anchoring nut 16 and the packing ring 18 of near-end in use.Anchoring nut 16 comprises complementary female thread, and it is configured to coordinate with the external screw thread 26 of the proximal end region of anchoring body 12 according to size design.The anchoring nut 16 of the anchoring body 12 of 3.2mm and the representative diameter of anchoring packing ring 18 are 3.2mm and 8mm respectively.
The remote area of the anchoring body 12 of threaded 28 by according to size design to extend at least partially in other contiguous bone sections or region, wherein it is coupled to anchor screw 14, as will be described.
B. anchor screw
As anchoring body 12, nuts and washers 18, anchor screw 14 can such as be formed by the durable material that can be used in prosthese technology by machining or molding equally, anchor screw 14 can enter in bone by spiral, and does not suffer the obvious bio-absorbable of surrounding bone or tissue along with the time or absorb.As other parts of compression assembly 10, anchor screw 14 is intended to being enough to make fracture or retaining in place in fusion site stable time.The example of such material includes but not limited to, titanium, titanium alloy, tantalum, chromium cobalt, surgical steel, or any other whole joint replacement metal and/or pottery, or its combination.
Anchor screw 14 is crossed over certain distance with the end of the threaded remote area 28 at anchoring body 12 by according to size design in other contiguous bone section or region.Illustrate as best in Fig. 2, anchoring body 14 comprises external spiral spiral shell ridge or screw thread 30, and its cylinder around anchor screw 14 is formed.External screw thread 30 is configured to increase in bone and screw when rotating, so that anchor screw 14 proceeds to by rotation and is received in the bone in bone section or region according to size design.Anchor screw 14 opposing be contained in bone moves axially and separates.Again according to topologic demand, the representative scope of the length of anchor screw 14 can between 5mm to 20mm.The representative diameter of anchor screw 14 is about 7mm.
Anchor screw 14 also comprises internal coiling spiral shell ridge or screw thread 32, and it is formed in the boring of anchor screw 14.Female thread 32 is configured to mate with external screw thread 28 complementary on the remote area of anchoring body 12 according to size design.When the female thread 32 being threaded onto anchor screw 14 and when mating with the female thread 32 of anchor screw 14, the remote area of anchoring body 12 is anchored to bone to resist moving axially of anchoring body 12 by anchor screw 14.As previously described, anchor screw 14 (at far-end) and anchoring nut 16 and anchoring packing ring 18 (at near-end) make anchoring body 12 pressurized, thus compress and fix bone section or contiguous bone region.
Alternatively, anchor screw 14 can be replaced by the parts without externally threaded inner threaded, it to be configured to such as by carrying out interference engagement and/or by using the alternate manner that fixes of binding agent to be attached in the boring of the opening of the bone section of distalmost end securely, the hole ends of this opening is in the bone section of distalmost end according to size design.As anchor screw 14, interference engagement and/or the whole implant structure of binding agent anchoring.Binding agent also can combinationally use with anchor screw 14.
C. implant structure
Implant structure 20 can such as be formed by machining, molding or the durable material extruded by can be used in prosthese technology, and this implant structure 20 does not suffer the obvious bio-absorbable of surrounding bone or tissue or absorbs along with the time.As other parts of compression assembly 10, implant structure 20 is intended to being enough to make fracture or retaining in place in fusion site stable time.Such material includes but not limited to, titanium, titanium alloy, tantalum, tivanium (aluminum, vanadium and titanium) chromium cobalt, surgical steel, or other whole joint replacement metal any and/or pottery, sintered glass, artificial bone, any uncemented metal or ceramic surface, or its combination.Alternatively, implant structure 20 can be formed by the combination such as biocompatible filling material of bone of suitable durable biomaterial or metal and biomaterial.Implant structure 20 can carry out molding by flowable biomaterial such as acrylic acid bone cement, and this flowable biomaterial is such as light-cured into not flowable materials or solid material by UV.
Implant structure 20 comes according to size design according to topology.Usually, medical professional can utilize the anatomical textbook of skeleton and they to the knowledge of position and i or I thereof to understand the form of partial structurtes.Doctor can also utilize such as planar film x-ray, cryptoscope x-ray on the basis of the ex ante analysis of the form in targeted bone region, or MRI or CT scan determine the size of implant structure 20.
As shown in Fig. 3 to Fig. 7, implant structure 20 can present different shapes and have different cross-sectional geometries.Implant structure 20 can have such as that general curve is (namely, circular or oval) cross section--as Fig. 3 for shown in diagram object-or the cross section (that is, square or rectangle or triangle)-if Fig. 4 is for shown in diagram object of straight line substantially--or its combination.In fig. 2, implant structure 20 is shown as leg-of-mutton cross section, and it has resisted rotation when implanting and micro-movement effectively.
As shown in Figure 5 and Figure 6, implant structure 20 (no matter be curve (Fig. 5) or straight line (Fig. 6)) at least can comprise conical region 34 along a part for its axial length, means that the width of implant structure 20 or diameter incrementally increase along its axial length.Desirably, conical region 34 is corresponding with the proximal end region (that is, the decline entering bone of implant structure 20) of implant structure 20 in use.The amount increasing progressively increase of width or diameter can change.As an example, for the implant structure 20 of normal diameter with 7mm, its maximum magnitude increasing progressively increase can in the scope about between .25mm to 1.25mm.Conical region 34 further enhancing generation and the maintenance of the compression between bone section or bone region.
In order to strengthen generation and the maintenance (see Fig. 7) of the compression between bone section or bone region further, implant structure 20 (though be curve or straight line or taper) surface 36 of the outstanding fastening bone of " tooth " or the wing or similar type can be comprised.Tooth or the wing 36 can stretch out such as 2 to 4mm from the surface of implant structure 20, and face on the near-end of implant structure 20 and the compression stress direction of far-end is along with it is by compressing together with compression assembly and being tightened onto in bone section.
Grow in bone or wear osteogenesis region 24 and can extend along the whole outer surface of implant structure 20, as shown in Figure 1 or 2, or grow or wear osteogenesis region 24 in bone and can only cover the distance that the either side of bone section or fracture line is specified.Growth district 24 or wear osteogenesis and can comprise in bone, such as, through hole, and/or different picture on surface, and/or different superficial makings, and/or hole, or its combination.Certainly, growth or the configuration of wearing osteogenesis region 24 can change in bone.By the mode of embodiment, growth or wear osteogenesis region 24 and can comprise open mesh configuration in bone; Or pearl configuration; Or girder configuration; Or comprise hole or window.Be of value in bone any configuration growing and/or wear osteogenesis will satisfy the demand.
In bone growth or wear osteogenesis region 24 can coated or parcel or surface treatment to provide in bone growth or to wear osteogenesis region, or it can be formed by such material, this material self has the structure being of value in bone and growing or wear osteogenesis inherently, such as porous web, hydroxyapatite, or other porous surface.Grow in bone or wear osteogenesis region and can comprise the hole allowing bone to grow in whole region.
In preferred embodiments, growth district or wear the plasma spray-painting that osteogenesis region 24 is included in the porous on implant structure 20 in bone.This generates on biomechanics tight fixing/emerging system, its be designed to support reliably fixing/merge and the weight capacity of acumen.
Grow or wear osteogenesis region 24 in bone and can be coated with other coating multiple such as antimicrobial, antithrombotic agent and osteoinductive agent further, or its combination.If wished, whole implant structure 20 can comprise such agent.
D. the implantation of constrictor assembly
In order to illustrated object, Fig. 8 A to Fig. 8 L diagrammatically shows the representative program for implanting constrictor assembly 10.More specifically, afterwards the anatomy of the concrete implanted prosthetics of the constrictor assembly 10 described in SI-joint is concentrated description.
Doctor identifies the bone section or contiguous bone region (see Fig. 8 A) that will be fixed or merge (arthrodesis).By the help of the visualization technique of routine, such as, the live image be shown on TV screen supplies (liveimagefeed) to utilize radioscopic image booster such as C-arc or cryptoscope to produce, directing pin 38 is introduced through bone section or the region of a vicinity by conventional device (see Fig. 8 B), by gap between or joint, and partly enter other contiguous bone section or region.
Overman bit 40 is through (passover) directing pin 38 (see Fig. 8 C) to be formed by the bone section of a vicinity or region, by gap between or joint, and the guide partly entering other contiguous bone section or region inserts passage or boring 42.Single drill bit or multiple drill bit 40 can be utilized to drill through GUSUIPIAN or bone surface to produce the guide's boring wishing size and configuration.Guide hole 42 the bone region of far-end do not holed and nature for holding anchor screw 14.When guide hole 42 complete time, remove overman bit 40.
The chisel 44 (in the embodiment shown in the drawing, this chisel 44 is leg-of-mutton) (see Fig. 8 D) with external shape and the size of mating with the external shape of implant structure 20 and size touches (tap) through directing pin 38 and holes 42 by guide.Be shaped chisel 44 along guide hole 42 edge cut with is formed hope profile (in the embodiment shown in the drawing, this chisel 44 is leg-of-mutton), to receive implant structure 20 by the bone section of a vicinity or region, by gap between or joint, and partly enter other contiguous bone section or region.
Chisel 44 is taken out (see Fig. 8 E), and anchor screw 14 (its female thread coordinates with the far-end of the threaded screwdriver 46 of tubulose) is through the end of directing pin 38 to the boring 48 of the opening of distal bone section.Anchor screw 14 crosses the boring 48 of opening end thread by the operation of screwdriver 46 be connected to do not bore and naturally in bone.Such as, anchor screw 14 can be to advance and the end crossing the boring 48 of opening to imbed in bone at least 5mm.
By reversely rotating from anchor screw 14, threaded screwdriver 46 is got out, and remove directing pin 38 (see Fig. 8 G).Insert anchoring body 12, and its threaded far-end 28 is threaded onto and coordinates (see Fig. 8 H) with the female thread 32 of anchor screw 14.
As shown in Fig. 8 H, due to its autotelic size and configuration, when its threaded far-end 28 is suitably threaded onto anchor screw 14, the threaded near-end 26 of anchoring body 12 stretches out the distance of exposure in the outside of the near-end of the boring 48 of opening.
Implant structure 20 by making it slide on anchoring body 12 through anchoring body 12, until the far-end of implant structure 20 is positioned at docking against the near-end (see Fig. 8 I) of anchor screw 14.
Anchoring packing ring 18 becomes docking by sliding on the threaded near-end 26 of the exposure of anchoring body 12 and againsts outside bone surface (see Fig. 8 J).The threaded near-end 26 that anchoring nut 16 is threaded onto anchoring body 12 coordinates (see Fig. 8 K) with the threaded near-end 26 of anchoring body 12.Manually (or power) chuck 50 is utilized anchoring nut 16 to be against anchoring packing ring 18 fastening (see Fig. 8 L), until pass through assembly 10 by the compression applications of desired amount in bone region.Compress the distance that will reduce between bone section, also make implant structure 20 compress in the boring 48 of opening simultaneously, guarantee the close contact between growth district 24 and bone in the bone in the boring 48 of opening.
Accelerated on implant structure 20, in implant structure 20 or by growing in the bone of implant structure 20 or wearing osteogenesis, to accelerate fusion process or healing time by the close contact growing or wear the surface along implant structure 20 that the compression between osteogenesis region 24 produces in bone.
As will be described herein in more detail afterwards, can implant more than 1 constrictor assembly 10 in given bone section.Such as, as (such as, see, Figure 20) that will describe afterwards, implantable three such constrictor assemblies are to make SI-joint fusion.
E. selectable embodiment
(1) far-end anchor plate
The selectable embodiment of constrictor assembly 10 is shown in Figure 31 to Figure 33.As has been described, in order to bone is fixed or the object of joint fusion, in use, constrictor assembly 10 is configured to implant in the adjacent bone section separated by gap or joint according to size design.
In this embodiment (see Figure 31), anchoring body 12, nut 16 and packing ring 18 are as described earlier is equally configured according to size design.Similarly, implant structure 20 is configured to the cross section of substantially straight line according to size design, also as described in the early time and as shown in Figure 4.
In this embodiment, replace threaded anchor screw 14, by the anchor plate 58 of cardinal principle straight line, the distal anchor of assembly 10 is affixed in bone.Anchor plate 58 is such as formed by the hard durable material that can be used in prosthese technology by machining or molding, anchor plate 58 can to inject in bone and to increase in bone and screw, and does not suffer the obvious bio-absorbable of surrounding bone or tissue along with the time or absorb.
Illustrate as best in Figure 31 and Figure 32, the anchor plate 58 of straight line is configured to mate with the cross section of the straight line of implant structure self according to size design.In illustrated layout, the cross section of implant structure 20 is general triangular, and therefore, the cross section of anchor plate 58 is also general triangular.Like this, anchor plate 58 comprises most advanced and sophisticated 64.The limit of the anchor plate 58 between tip is sharpened to comprise bone-cutting edge 72.
Anchor plate 58 also comprises boring 60 (see Figure 31) in its geometric center.Internal coiling spiral shell ridge or screw thread 62 are formed in boring 68.Female thread 62 is configured to coordinate with the external screw thread 28 of the complementation on the remote area of anchoring body 12 according to size design.Thus the far-end of anchoring body 12 may be threadably connected to anchor plate 58 (as shown in figure 32).When being threaded onto anchoring body 12, anchor plate 58 and anchoring body 12 jointly rotate (as shown in figure 33).
Before in the boring 48 of the opening formed in mode implant structure 20 being introduced previously describe (and as shown in Fig. 8 A to Fig. 8 D), anchoring body 12 is through the boring 22 of implant structure 20, and anchor plate 58 is threadingly attached to the threaded region 26 of far-end of anchoring body 12, its by according to size design to extend over the far-end of implant structure 20.And as shown in figure 32, anchor plate 58 is oriented to the position of aliging with the far-end of implant structure 20 in addition rotatably.In the position of alignment (Figure 32), the tip 64 of anchor plate 58 is overlapping with the tip 66 of the far-end of implant structure 20 and aim at.Implant structure 20, anchoring body 12 and anchor plate 58 are introduced as unit with the boring 48 of the orientation shown in Figure 32 through opening.In the position of alignment, anchor plate 58 pairs of implant structures 20 do not provide resistance through the passage of the boring 48 of opening.
When the end of the boring of contact openings, the near-end of anchoring body 58 rotates 60 degree (as shown in Figure 33).During rotation, anchor plate 58 moves in the position of fastening bone of extension, and (as shown in Figure 33) is no longer alignd in this position with the far-end of implant structure 20.In the position of the fastening bone extended, the far-end that anchor plate 58 is present in implant structure 20 is radially outward stretched out from the triangle edges 68 of implant structure 20 in the tip 64 of leg-of-mutton anchor plate 58, there is the lateralarea being greater than the expansion of the cross-sectional area of implant structure self.
In the process that anchor plate 58 rotates to the position of fastening bone, the cutting edge 72 of anchor plate 58 to proceed in bone and cuts bone, is contained in by anchor plate 58 (see Figure 34) in the bone in bone section or region.In the position of fastening bone, the distal anchor of anchoring body 12 is affixed in bone by anchor plate 58.Anchor plate 58 is resisted in the mode identical with anchor screw 140 points and is moved axially and separate.
Otch 70 (see Figure 31 and Figure 32) is preferably included on the limit 68 of the implant structure 20 of the far-end of structure 20.Otch 70 is also configured according to size design to be made when anchor plate 58 rotates to the position of its fastening bone, adjoins the body lock (detent) of most advanced and sophisticated anchor plate 58 and rests in otch 70, as shown in figure 33.Be nested in otch 70, make further the anchoring nut 16 of the near-end of anchoring body 12 and packing ring 18 fastening, as described earlier, anchor plate 58 is locked in the anchorage point of fastening bone.By fastening anchoring nut, implant structure compresses (as shown in figure 34) between far-end anchor plate 58 and near-end nut/washer, thus forms constrictor assembly 10.
(2) the compressible implant structure of two-piece type
The selectable embodiment of compressible implant structure is shown in Figure 35 A and Figure 35 B.As has been described, in order to bone is fixed or the object of joint fusion, in use, implant structure is configured to implant in the adjacent bone section separated by gap or joint according to size design.
In this embodiment (see Figure 35 A), implant structure can have cross section that is as described earlier circular or curve.Unlike previous implant structure, the implant structure 20 shown in Figure 35 A comprises two implant components 74 and 78 coordinated.
As previously described, each implant structure 74 and 78 can such as be formed by machining, molding or the durable material extruded by can be used in prosthese technology, and these implant components do not suffer the obvious bio-absorbable of surrounding bone or tissue or absorb along with the time.Each implant structure 74 and 78 comprises the interior growth of outside bone as described earlier or wears osteogenesis region.
Before being introduced by implant structure, form the boring of the opening through bone section in the previous mode shown in described and Fig. 8 A to Fig. 8 D.Implant component 74 to be configured to such as by carrying out interference engagement and/or by using the alternate manner that fixes of binding agent to be attached in the boring of the opening of the bone section of distalmost end securely, the hole ends of this opening is in the bone section of distalmost end according to size design.Implant component 74 is intended to the whole implant structure of anchoring.
Implant component 74 also comprises pillar 76, and its boring extending through opening enters in the bone section of most proximal end, and the boring of opening comes from the bone section of this most proximal end.Pillar 76 comprises female thread 80.
Second implant component 78 to be configured in the boring of the opening of the bone section being incorporated into most proximal end according to size design.Second implant component 74 comprises internal bore, so that implant component 78 is installed by the pillar 76 being slid past the first implant component 74, as shown in Figure 35 B.
Anchor screw 16 (desirably, with packing ring 18) comprises external screw thread, and it is configured to coordinate with the female thread 80 of the complementation in pillar 76 according to size design.Fastening anchor screw 16 makes the first and second implant components 74 and 78 engage, and the implant structure of gained is compressed, as shown in Figure 35 B.
(3) radial compression
(implant structure of separation)
The selectable embodiment of implant structure 82 is shown in Figure 36 A and Figure 36 B.As has been described, in order to bone is fixed or the object of joint fusion, in use, implant structure 82 is configured to implant in the adjacent bone section separated by gap or joint according to size design.Implant structure 82 is configured to be in radial compression according to size design.
Implant structure 82 comprises the main body of the cross section can as described earlier with circle or curve.As previously described, implant structure 82 can such as be formed by machining, molding or the durable material extruded by can be used in prosthese technology, and this implant structure 82 does not suffer the obvious bio-absorbable of surrounding bone or tissue or absorbs along with the time.Implant structure 82 comprises the interior growth of one or more outside bone as described earlier or wears osteogenesis region.
Be different from previously described implant structure, the near-end of implant structure 82 comprises the axial region of the weakening region comprising crack (split) 84.Also comprise self-tapping screw (self-tappingscrew) 16.Screw 16 comprises the threaded main body of taper.The main body of taper forms the chock of increased diameter on the direction of the head towards screw 16.Screw 16 is self tappings, being configured to little by little to advance when rotating in crack 84, producing the screw thread of himself, as shown in figure 36b simultaneously according to size design.
Before being introduced by implant structure 84, form the boring of the opening by bone section in the previous mode shown in described and Fig. 8 A to Fig. 8 D.As shown in Figure 36 A, implant structure 84 is introduced in the boring of opening.Implant structure 84 to be configured to such as by carrying out interference engagement and/or by using the alternate manner that fixes of binding agent to be attached in the boring of the opening of the bone section of distalmost end with fixing, the hole ends of this opening is in the bone section of distalmost end according to size design with being supposed to.Interference engagement and/or the whole implant structure 84 of binding agent anchoring.
After implant structure 84 being introduced the boring of opening, self-tapping screw 16 (desirably, having packing ring 18) advances progressively by rotating in crack 84.The threaded main body of the cleat shape of screw 16 promotes the main body of implant structure 84 gradually along crack 84 radial outward expansion, as shown in figure 36b.The diameter of the main body of implant structure 82 oppresses the near-end of implant structure 82 and contiguous bone close contact about the expansion in crack 84.The main body of implant structure 82 makes the near-end of implant structure 82 against bone about the radial expansion in crack 84 and produces compression.Radial compression guarantees the close contact between the bone in the boring of growth district and opening in bone, and has resisted in rotary moving in bone section of implant structure 82 and moved axially.
F. the implant structure of uncompressed
Should understand, there is growth in bone and/or wear osteogenesis region elongated bar sample implant structure 20 (that as shown in Figure 2) can by according to size design and be configured to when be not associated with constrictor assembly 10 as described or other device not used for the compression realizing implant structure as described fixing fracture (that is, the part of fixing same bone) or fixes will merge (arthrodesis) to the bone in whole health.When not being associated with constrictor assembly 10, for fixing fracture (namely, the part of fixing same bone) or such as describe be that the serial number submitted on May 24th, 2005 is 11/136 for there is growth in bone and/or wearing the configuration of representational elongated bar sample implant structure 20 in osteogenesis region 24 and purposes of the fixing bone that will merge, in U.S.'s turn of tidal stream application of 141, it is incorporated to by reference at this.
II. the arthrodesis of the sacroiliac joint of implant structure is utilized
Bar sample implant structure 20 (and selectable embodiment) elongated as shown in Figure 2 to make when associating with constrictor assembly 10 or do not associate fixing (respectively shown in the front view of Fig. 9 and Figure 10 and rearview) SI-joint in a minimally invasive manner become possibility.These implant structures 20 are implanted effectively by utilizing two kinds of optional surgical methods; That is, (1) side direction method, or (ii) rear side is to method.Help any one program by the side direction of routine and/or anterior-posterior (A-P) visualization technique, such as, utilize radioscopic image booster such as C-arc or cryptoscope to produce to be shown in the live image supply on TV screen.
A. side direction method
(1) unconnected with constrictor assembly
In an embodiment of side direction method (see Figure 11, Figure 12 and Figure 13 A/B), one or more implant structure 20 is laterally introduced (when not using constrictor assembly 10) by ilium, SI-joint enter rumpbone S1.The layout of implant structure 20 best illustrating this passage in Figure 12 and Figure 13 A/B and obtain.In the embodiment shown in the drawing, placed three implant structures 20 by this way.In addition, in the embodiment shown in the drawing, the cross section of implant structure 20 is leg-of-mutton, it should be understood that, can utilize the implant structure 20 of other cross section as described earlier.
Before carrying out side direction implant procedure, doctor utilizes the injection of the Faber in such as SI joint test or CT-guiding or X-ray/MRI to identify the SI-joint segments will fixing or merge (arthrodesis).
Under the help of side direction and anterior-posterior (A-P) c-arc, and patient lies prone position (prostrate) recumbency, doctor's (utilizing lateral visual) aligns greater sciatic notch (greatersciaticnotche) to provide real lateral position.Align with the rear cortex of canalis sacralis and start the otch of 3cm, then blood-tissue separation is carried out to ilium.By lateral view, directing pin 38 (having sleeve) (such as, Si Tanman pin) starts in the below of rumpbone S1 end plate and position just before canalis sacralis rests on ilium.A-P figure and lateral view in, directing pin 38 should with little angle onwards (such as, as shown in FIG. 13A dried up put down 15 ° to 20 °) be parallel to S1 end plate.In lateral view, directing pin 38 should after rumpbone antetheca.In A-P figure, directing pin 38 should on S1 bottom hole and the side of center line.This is substantially corresponding to the order shown in diagram in Fig. 8 A and Fig. 8 B.Before removing directing pin 38 sleeve, soft tissue protector (not shown) desirably slips over directing pin 38 and firmly againsts ilium.
42 are holed, as diagram display in Fig. 8 C through directing pin 38 (and by soft tissue protector) guide that holes in the previously described manner.Guide holes and 42 extends through ilium, enter S1 by SI-joint.Remove drill bit 40.
The chisel 44 be shaped is touched guide through directing pin 38 (and passing through soft tissue protector) hole to produce the boring 48 of the opening of the expectation profile had for implant structure 20 in 42, this implant structure 20 is leg-of-mutton in the embodiment shown in the drawing.This is substantially corresponding to the order of Fig. 8 D diagram display.The triangular-shaped profile of the boring 48 of opening also shows with Figure 11.
As shown in fig. 11 and fig; triangle implant structure 20 is touched at once (in this embodiment through directing pin 38 by soft tissue protector; be not associated with compression sleeve assembly) by ilium, stride across SI-joint and enter S1, until the sidewall that the near-end of implant structure 20 againsts ilium flushes (also see Figure 13 A and Figure 13 B).Take out directing pin 38 and soft tissue protector, make implant structure 20 be in the passage of opening, concordant with the sidewall of ilium (see Figure 13 A and Figure 13 B).In the embodiment shown in the drawing, the implant structure 20 that implantation two is extra by this way, as Figure 12 the best illustrates.
The size of implant structure 20 is determined according to topology.For SI-joint, according to topology, the large I of representational implant structure 20 to be about from about 35mm to about 55mm and diameter in the scope of 7mm in length and to change.Usually, medical professional can utilize the anatomical textbook of skeleton and they to the knowledge of position and i or I thereof to understand the form of partial structurtes.Doctor can also utilize such as planar film x-ray, cryptoscope x-ray on the basis of the ex ante analysis of the form in targeted bone region, or MRI or CT scan determine the size of implant structure 20.
(2) be associated with constrictor assembly
As shown in Figure 14 to Figure 16 A/B, side direction method is also applicable to introduce one or more implant structures 20 of being associated with constrictor assembly 10 as described earlier, laterally through ilium, SI-joint enter rumpbone S1.The layout of implant structure 20 best illustrating this passage in Figure 16 A and Figure 16 B and obtain.As the embodiment as shown in Figure 11 to Figure 13 A/B, placed three implant structures 20 by this way.In addition, as the embodiment as shown in Figure 11 to Figure 13 A/B, the cross section of implant structure is leg-of-mutton, but still should be understood that the implant structure that can utilize and have other cross section as described earlier.In this embodiment of side direction method, after the boring 48 forming opening, do not insert implant structure 20 immediately.On the contrary, first the parts of constrictor assembly 10 are installed in the boring 48 of opening to receive implant structure 20.
More specifically, after the boring 48 forming opening, as described earlier, remove directing pin 38, soft tissue protector is kept in place simultaneously.The anchor screw 14 of constrictor assembly 10 is in the bone of the rumpbone S1 of the end of the boring 48 of crossing opening in the mode shown in Fig. 8 E to Fig. 8 G substantially.In this arrangement, in order to hold the layout of the anchor screw 14 of constrictor assembly 10, cross guide hole 42 and opening boring 48 end naturally and the bone to a certain degree do not retained with holing in rumpbone S1.Anchor screw 14 advances and imbeds naturally and in the bone of not holing of this degree in rumpbone S1, as shown in Figure 16 A and Figure 16 B, to be coupled to the threaded far-end 28 of anchoring body 12.
The threaded near-end 28 of anchoring body 12 is threaded onto and coordinates with the anchor screw 14 in rumpbone S1, as described earlier and as shown in Fig. 8 H, and the remainder of anchoring body 12 proximally extends through SI-joint and ilium, the distance of exposure is stretched out, as shown in Figure 16 A and Figure 16 B with the outside of the sidewall at ilium.Then, implant structure 20 is placed by it being slided on anchoring body 12, until the sidewall that against ilium flushes, as described earlier and as shown in Fig. 8 I.Then anchoring packing ring 18 and nut be installed and secure it on the near-end of anchoring body 12, as described earlier and as shown in Fig. 8 J to Fig. 8 L, assembly is compressed.The assembly obtained is shown in Figure 15 and Figure 16 A/B.
As shown in figure 14 and figure 15, stride across SI-joint by side direction method and three constrictor assemblies 10 are installed.Because single constrictor assembly is placed compressively by fastening anchoring nut 16, the sidewall that the implant structure of contiguous constrictor assembly can advance to cross ilium stretches out slightly.If this situation occurs, then the implant structure 20 stretched out can touch in ilium further lightly through its anchoring pins 12 separately.
B. rear side is to method
(1) unconnected with constrictor assembly
As shown in Figure 17 to Figure 19 A/B, side direction method can introduce one or more implant structure (and not using constrictor assembly 10), after the ilium of ilium, sour jujube enters later, angledly ends at the sacrum wing by SI-joint.The layout of implant structure 20 best illustrating this passage in Figure 18 and Figure 19 A/B and obtain.In the embodiment shown in the drawing, placed three implant structures 20 by this way.In addition, in the embodiment shown in the drawing, the cross section of implant structure 20 is leg-of-mutton, it should be understood that, can utilize the implant structure 20 of other cross section as described earlier.
Rear side relates to few soft tissue destruction to method than side direction method, because the soft tissue of the inlet point of sour jujube after there is the ilium of less covering ilium.Therefore, introduce from this region implant structure 20 make less, more flexibly otch become possibility.And implant structure 20 passes more bone along rear lateral approach than the approach of complete side direction, thus relates to the more surface area in SI-joint and cause the more fusion in SI-joint and better fix.Utilize rear side can also get around to method the whole nerve rooies comprising L5 nerve root.
Substantially identical with the device for side direction method for the device of rear side to method.Desirably, relate to utilize the Faber in such as SI joint test or CT-guiding injection or X-ray/MRI identify the SI-joint segments will fixing or merge (arthrodesis).Desirably, to carry out under the help of side direction and anterior-posterior (A-P) c-arc at patient lies prone position (prostrate) recumbency.Now, except guide hole 42 path from sour jujube after the ilium of ilium initial, angledly to be ended at beyond the sacrum wing by SI-joint, utilize identical Surigical tool to form guide through directing pin 38 and hole 42.(be shown in Figure 17) as previously described, utilize chisel guide to be holed 42 profiles being configured as expectation, and by implant structure 20 with in the boring 48 of the mode insertion opening shown in Figure 18 and Figure 19 A/B.Leg-of-mutton implant structure 20 is touched (in this embodiment through directing pin 38; be not associated with compression sleeve assembly 10) pass through soft tissue protector; sour jujube after the ilium of ilium; angled by SI-joint; and end at the sacrum wing; until the near-end of implant structure 20 against the ilium of ilium after sour jujube flush, as shown in figure 18.As shown in Figure 17 to Figure 19 A/B, introduce three implant structures 20 by this way.Due to the anatomic morphological of the bone along rear lateral approach, the implant structure of different size is introduced in suggestion, and wherein the length of most the superior is the longest, and other length is shorter.
(2) be associated with constrictor assembly
As shown in Figure 20 to Figure 22 A/B, rear side is also applicable to self to method and introduces the one or more implant structures 20 be associated with constrictor assembly 10 as described earlier, after the ilium of ilium, sour jujube enters, and is angledly proceeded in the sacrum wing by SI-joint.The layout of the implant structure 20 with constrictor assembly 10 best illustrating this passage in Figure 22 A/B and obtain.As the embodiment as shown in Figure 17 to Figure 19 A/B, placed three implant structures 20 by this way.In addition, as in the embodiment as shown in Figure 17 to Figure 19 A/B, the cross section of implant structure 20 is leg-of-mutton, but should also be understood that the implant structure 20 that can utilize other cross section as described earlier.In rear side this embodiment to method, after the boring 48 forming opening, do not insert implant structure 20 immediately.But first the parts of constrictor assembly 10 are installed in the boring 48 of opening to receive implant structure 20 by previously to have described as shown in Figure 20.
As previously described, substantially identical with the device for side direction method for the device of rear side to method.Desirably, to carry out under the help of side direction and anterior-posterior (A-P) c-arc at patient lies prone position (prostrate) recumbency.Utilize identical Surigical tool to form guide through directing pin 38 and hole 42, it is initial from sour jujube after the ilium of ilium, angledly ends at the sacrum wing by SI-joint.As described earlier and as shown in Figure 20, chisel 44 is utilized guide to be holed 42 profiles being configured as expectation.In this arrangement, in order to hold the layout of the anchor screw 14 of constrictor assembly 10, the guide crossing formation hole 42 and opening boring 48 end naturally and the bone to a certain degree do not retained with holing in the sacrum wing.Anchor screw 14 advances and imbeds naturally and in the bone of not holing of this degree in the sacrum wing, as shown in Figure 22 A/B, to be coupled to the threaded far-end 28 of anchoring body 12.Due to the form of the sacrum wing, anchor screw 14 can be shorter than the anchor screw 14 imbedded in rumpbone S1 by side direction method.
The threaded near-end 28 of anchoring body 12 is threaded onto and coordinates with the anchor screw 14 in the sacrum wing, as described earlier and as shown in Fig. 8 H, and the remainder of anchoring body 12 proximally extends through SI-joint to stretch out the distance of exposure in the outside of the suprailium sour jujube of ilium, as shown in Figure 21 to Figure 22 A/B.Then, implant structure 20 is placed by it being slided on anchoring body 12, until the suprailium sour jujube that against ilium flushes, as described earlier and as shown in Fig. 8 I.Then anchoring packing ring 18 and nut be installed and secure it on the near-end of anchoring body 12, as described earlier and as shown in Fig. 8 J to Fig. 8 L, assembly 10 is compressed.The assembly 10 obtained is shown in Figure 21 and Figure 22 A/B.
As shown in figs. 20 and 21, stride across SI-joint by rear side to method and three constrictor assemblies 10 are installed.As previously described, because single constrictor assembly 10 is placed compressively by fastening anchoring nut 16, the suprailium sour jujube that the implant structure 20 of contiguous constrictor assembly 10 can advance to cross ilium stretches out slightly.If this situation occurs, then the implant structure 20 stretched out can touch in the suprailium sour jujube of ilium further lightly through its anchoring body 12 separately.
C. conclusion
Utilize posterior approach or rear side to method, when associating with constrictor assembly 10 or do not associate or it combines, in the mode of Wicresoft one or more implant structure 20 can be inserted individually and stride across SI-joint, as described.Conventional organize entering tool, match device, intubate and/or drill bit can be used for this purpose.Formation insert passage or insert before implant structure 20 do not need joint to prepare, removing cartilage or disintegration (scraping), therefore need to be formed probably with or the insertion passage of the about Wicresoft of the maximum outside diameter sizing of implant structure 20.
The implant structure 20 be associated with constrictor assembly 10 or do not associate eliminates the demand of autologous bone transplanting material, extra band base of a fruit screw and/or bar, hollow modularity anchor screw, tubular compression screw, IA screw thread cage or fracture fixation screw.
In exemplary process, may one to six be needed according to the size of patient and the size of implant structure 20, perhaps eight implant structures 20.After installation, suggestion patient prevents the load in SI-joint in fusion process.According to health and his or she the adhering to post-surgical protocols of patient, this can be the cycle in six to ten two weeks or more.
Implant structure 20 makes to invade surgery operating technology that is little and that do not have a large amount of soft tissues to peel off than the surgical operation of traditional opening becomes possibility.To method, the simple surgical method with the surgery operating technology complementation of Wicresoft is provided to the side direction method in SI-joint and rear side.It is minimum that the profile of implant structure 20 and design make rotation and fine motion drop to.The hard implant structure 20 be made of titanium provides the stability in postoperative SI joint at once.In the bone comprising the plasma spray-painting of the porous with irregular surface, growth district 24 provides stable bone to fix/merge.Implant structure 20 and surgical method make the layout of larger fusion surface area become possibility, this layout is designed to postoperative weight bearing capabilities is maximized and provides biomechanics accurate implant, and this implant is specifically designed to the SI-joint stability making mass loading.
III. the arthrodesis of the sacroiliac joint of other structure is utilized
Under the side direction of routine and/or the help of front portion-rear portion (A-P) visualization technique, to the side direction method in SI-joint and rear side to method make to utilize other form fixing/fusion structure fixes SI-joint in the mode of Wicresoft becomes possibility.Any one method makes minimum size incision and the stripping of minimum soft tissue, the stimulation of minimum tendon, less pain, the infection of reduction and the danger of complication, and minimum blood loss becomes possibility.
Such as (see Figure 23 and Figure 24 A/B), side direction method described herein can be utilized to introduce one or more screw spline structure 52, such as, hollow modularity anchor screw or tubular compression screw, or fracture fixation screw, it is laterally placed, through ilium, SI-joint enter rumpbone S1.The layout of screw spline structure 52 showing this passage in Figure 23 and Figure 24 A/B and obtain.Desirably, screw spline structure to adopt in bone as described growth material or wears osteogenesis configuration, and is configured to stop rotation after the implantation according to size design.
Similarly, rear side described herein can be utilized to introduce in screw spline structure 52 to method one or more, after the ilium of ilium, sour jujube enters, angled by SI-joint, and ends at the sacrum wing.The layout of screw spline structure showing this passage in Figure 25 and Figure 26 A/B and obtain.Desirably, screw spline structure 52 to adopt in bone as described growth material or wears osteogenesis configuration, and as previously described, is configured to stop rotation after the implantation according to size design.
As another example, side direction method as described herein can be utilized to introduce and comprise one or more fusion cage structures 54 of bone grafting material, it is laterally disposed through ilium, SI-joint enter rumpbone S1.The layout of fusion cage structure 54 showing this passage in Figure 27 and Figure 28 A/B and obtain.Such structure 54 can comprise anchor screw parts 56, and it is arranged in rumpbone S1, as shown in Figure 27 and Figure 28 A/B.
Similarly, rear side described herein can be utilized to introduce in fusion cage structure 54 to method one or more, after the ilium of ilium, sour jujube enters, angled by SI-joint, and ends at the sacrum wing.The layout of fusion cage structure 54 showing this passage in Figure 29 and Figure 30 A/B and obtain.Such structure 54 can comprise anchor screw parts 56, and it is arranged in the sacrum wing, as shown in Figure 27 and Figure 28 A/B.
IV. conclusion
Aforementioned aspect is only considered to the example of principle of the present invention.In addition, due to for a person skilled in the art, many improvement and change are easy to occur, therefore undesirably limit the invention to shown and the accurate structure described and operation.Although describe preferred embodiment, can change details without deviating from the invention, the present invention is defined by the claims.